Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

NCT00310856 | Completed Phase 2 Results

• 1 other identifier: V59P9
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Conditions

Meningococcal Meningitis

Keywords

meningitis; children; vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule

  Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\_12 M group)

  Before and 1 month after 2-dose or 1-dose schedule

Secondary Outcomes (9)

• Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule

  Before and 1 month after 2-dose or 1-dose schedule

• Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule

  Before and 1 month after 2-dose or 1-dose schedule

• Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age

  Before and 1 month after MenC-CRM vaccination at 12 months

• Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age

  Before and 1 month after MenC-CRM vaccination at 12 months

• Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age

  Before and 1 month after MenACWY-CRM vaccination at 18 months

Study Arms (3)

MenACWY-CRM_6-12 M

EXPERIMENTAL

Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)

Biological: MenACWY-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella

MenACWY-CRM_12 M

EXPERIMENTAL

Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)

Biological: MenACWY-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella

MenC-CRM_12 M_MenACWY-CRM_18 M

EXPERIMENTAL

Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)

Biological: MenACWY-CRM; Biological: MenC-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella

Interventions

MenACWY-CRM BIOLOGICAL

Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.

Also known as: Meningococcal ACWY conjugate vaccine

MenACWY-CRM_12 M; MenACWY-CRM_6-12 M; MenC-CRM_12 M_MenACWY-CRM_18 M

MenC-CRM BIOLOGICAL

One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.

Also known as: Meningococcal C conjugate vaccine

MenC-CRM_12 M_MenACWY-CRM_18 M

DTaP-Hib-IPV BIOLOGICAL

Also known as: Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel

MenACWY-CRM_12 M; MenACWY-CRM_6-12 M; MenC-CRM_12 M_MenACWY-CRM_18 M

PC7 BIOLOGICAL

One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.

Also known as: Heptavalent conjugate pneumococcal; Prevnar

MenACWY-CRM_12 M; MenACWY-CRM_6-12 M; MenC-CRM_12 M_MenACWY-CRM_18 M

MMR BIOLOGICAL

Also known as: Measles, mumps and rubella

MenACWY-CRM_12 M; MenACWY-CRM_6-12 M; MenC-CRM_12 M_MenACWY-CRM_18 M

Varicella BIOLOGICAL

MenACWY-CRM_12 M; MenACWY-CRM_6-12 M; MenC-CRM_12 M_MenACWY-CRM_18 M

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects eligible for enrollment in the study were healthy infants:
• who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;
• who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
• for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
• who were available for all the visits scheduled in the study;
• who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.
• Subjects eligible for enrollment in the study were healthy infants:
• who were 12 months old;
• who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;
• for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
• who were available for all the visits scheduled in the study;
• who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.

You may not qualify if:

• Subjects were not to be included in this study if:
• their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
• they previously received any meningococcal vaccine;
• they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
• they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
• they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;
• they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);
• they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):
• any immunosuppressive therapy since birth;
• immunostimulants since birth;
• any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days;
• they had a suspected or known HIV infection or HIV-related disease;
• they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;
• they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
• they had a history of seizure disorder:

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Children's Hospital of Eastern Ontario Research Institute

Ottawa, Ontario, K1H 8L1, Canada

Location

Herridge Community Health Clinic

Ottawa, Ontario, K1S 0G8, Canada

Location

Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center

Halifax, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningitis

Interventions

MenACWY-CRM vaccine; MenC-CRM vaccine; serogroup C meningococcal conjugate vaccine; diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine; Tetanus Toxoid; pentacel; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines, Combined

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Scott Halperin, Dr.

  Novartis Vaccines & Diagnostics

  PRINCIPAL INVESTIGATOR

• Francisco Diaz-Mitoma, Dr.

  Novartis Vaccines

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: June 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 9, 2018
• Results First Posted: November 1, 2013

Record last verified: 2018-09

Locations

CA (3)